Actively Recruiting
Antibiotic Duration and Outcomes in High-Risk Febrile Neutropenia Patients
Led by Humanitas University · Updated on 2026-01-28
172
Participants Needed
1
Research Sites
81 weeks
Total Duration
On this page
Sponsors
H
Humanitas University
Lead Sponsor
M
Ministry of education, university and research, Italy
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if a personalized duration of antibiotic therapy, based on clinical stability, is as effective as a standard duration of at least 10 days in hospitalized patients with hematologic malignancies (such as leukemia or lymphoma) who develop febrile neutropenia and Gram-negative bacteraemia. The main questions it aims to answer are: * Can a personalized antibiotic duration increase the number of days free from anti-Gram-negative therapy within 28 days without compromising patient safety? * How does the duration of antibiotic therapy (short vs. prolonged) affect the rate and modality of gut microbiota reconstitution? Researchers will compare: * Group A (Personalized Duration): Antibiotics are stopped after the patient maintains clinical stability (no fever and stable vital signs) for 72 consecutive hours. * Group B (Standard of Care): Antibiotics are continued for a standard duration, typically at least 10 days, based on current clinical surveys and physician decision. Participants will: * Be randomized to receive either the personalized or the standard duration of antibiotic therapy once a Gram-negative infection is confirmed in the blood. * Be monitored for 28 days to assess for new fever episodes, recurrence of infection, and overall survival. * If participating in the microbiological sub-study, provide biological samples (blood, feces, and rectal swabs) at specific time points (at the onset of fever, at the end of treatment, and at day 28). * Undergo specialized laboratory testing (Whole Metagenomic Sequencing) on the collected samples to evaluate the evolution of their intestinal and blood microbiota and the presence of antibiotic-resistant genes.
CONDITIONS
Official Title
Antibiotic Duration and Outcomes in High-Risk Febrile Neutropenia Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with a hematologic malignancy eligible for chemotherapy, bone marrow transplant, or CAR-T therapy
- Febrile neutropenia defined by fever (oral temperature ≥38.3°C once or ≥38.0°C sustained for 1 hour) and neutropenia (absolute neutrophil count < 1000 cells/microL)
- Expected duration of neutropenia of 7 days or more
- Bacteraemia diagnosed by positive blood cultures for non-contaminant microorganisms
- Isolation of Gram-negative bacterial species
You will not qualify if you...
- Diagnosis of pneumonia
- Diagnosis of intra-abdominal infections including neutropenic enterocolitis or biliary tract infection
- Persistently positive blood cultures at time of randomization
- Any condition deemed unsafe by the treating physician
AI-Screening
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Trial Site Locations
Total: 1 location
1
Microbiology and Virology - IRCCS Humanitas Research Hospital
Rozzano, Milan, Italy, 20089
Actively Recruiting
Research Team
V
Valeria Cento, MD, PhD
CONTACT
M
Michele Bartoletti, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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